Del 1: Koboltbaserade Iegeringar (ISO :1994) (ISO :1994)

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1 Dental base metal casting alloys - Tandvård - Basmetallegeringar - Part 1: Cobalt-based alloys Del 1: Koboltbaserade Iegeringar (ISO :1994) (ISO :1994) The European Standard EN ISO :1996 has the status of a Swedish Standard. This document contains the official English version of EN ISO :1996. Swedish Standards corresponding to documents referred to in this Standard are listed in Catalogue of Swedish Standards, issued by SIS. The Catalogue lists, with reference number and year of Swedish approval, International and European Standards approved as Swedish Standards as well as other Swedish Standards. Europastandarden EN ISO :1996 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO : Motsvarigheten och aktuliteten i svensk standard till de publikationer som omnämns i denna standard framgår av Katalog över svensk standard, som ges ut av SIS. I katalogen redovisas internationella och europeiska standarder som faställts som svenska standarder och övriga gällande svenska standarder.

3 English version Dental base metal casting alloys - Part 1: Cobalt-based alloys (ISO :1994) Alliages dentaires non précieux à couler Edelmetallfreie Dental-Gußleierungen Partie 1: Alliages à base de cobalt Teil 1: Kobalt-Basis Legierungen (ISO :1994) (ISO :1994) This European Standard was approved by CEN on CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

4 Foreword The text of the International Standard from Technical Committee ISO/TC 106 Dentistry of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 55 Dentistry, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 1997, and conflicting national standards shall be withdrawn at the latest by April ISO 6871 consists of the following parts, under the general title Dental base metal casting alloys : Part 1: Cobalt-based alloys Part 2: Nickel-based allóys Annex A forms an intgral part of this part of ISO Annex B is for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ice- -- land, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO :1994 was apporved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative)

Dental base metal casting alloys Part 1: Cobalt-based alloys 1 Scope This part of ISO 6871 specifies requirements and test methods for cobalt-based dental casting alloys suitable for use in

5 Dental base metal casting alloys Part 1: Cobalt-based alloys 1 Scope This part of ISO 6871 specifies requirements and test methods for cobalt-based dental casting alloys suitable for use in fabrication of removable dental appliances. It does not apply to alloys intended for use in fabrication of metal-ceramic dental restorations, 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 6871, At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 6871 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. 3.2 alloying element: Metallic or non-metallic elements added to or retained by a basic metal for the purpose of giving that metal certain special properties. 3.3 impurity: Metallic or non-metallic elements present but which are not intentionally added to or retained by a metal. 3.4 casting alloy: Alloy primarily intended for the production of castings. 3.5 base metal casting alloy: Casting alloy in which cobalt or nickel is the basic metallic element. 3.6 cobalt-based dental casting alloy: Dental casting alloy in which cobalt is the constituent present in the highest percentage by mass (main constituent). 4 Requirements ISO 3696:1987, Water for analytical Iaboratory use Specification and test methods. ISO 6892:1984, Metallic materials - Tensile testing. 4.1 Composition The chemical composition of the meet the following requirements: casting alloy shall ASTM-B , Recommended practice for descaling and cleaning titanium and titanium alloy surfaces. 3 Definitions For the purposes of this part of ISO 6871, the following definitions apply. 3.1 alloy: Metallic substance consisting of a mixture of the basic metallic element (the element predominating by mass) and other elements such as alloying elements and impurities. Cobalt Chromium Molybdenum Cobalt + Nickel + Chromium main constituent not less than 25 % (m/m) not less than 4 % (m/m) not less than 85 % (m/m) Constituents of the alloy in excess of 20 % (m/m) shall be within 2 % (m/m) of the value stated [see clause 8 b) and 9.2 d)]. Constituents in excess of

6 2 % (m/m) but not in excess of 20 % (m/m) shall be within 1 % (m/m) of the value stated [see clause 8 b) and 9.2 d)]. The percentage of nickel shall not be greater than the percentage indicated on the package label or insert (see clause 8). Other compositions with cobalt as the basic metallic element may be permissible subject to approval by regulatory authorities (see the Introduction). For such alloys, all alloying elements with more than 0,1 % (m/m) shall be given on the package or in the accompanying literature. 4.2 Biocompatibility See the Introduction for guidance on biocompatibility. 4.3 Corrosion resistance See the Introduction for guidance on corrosion resistance. Testing shall be in accordance with annex A. The total of the mean aggregate quantity of ions released shall be reported as specified in A Mechanical properties When tested in accordance with 7.3 and 7.4, the mechanical properties of the alloy shall comply with table 1. 5 Sampling Table 1 Mechanical properties The sample shall be adequate to prepare the specimens required for 6.2 and A.1, and shall be from one batch. Further sample and packaging shall be made available for visual inspection and analytical procedures in accordance with 7.1 and Preparation of test specimens 6.1 General Prepare the test specimens by the lost wax process of investment casting generally used in a dental laboratory, following the manufacturer s instructions for use. Cleanly separate the test specimens from sprues, freed of casting beads, parting lines and surface impurities and then grit blast the specimens. Replace any test specimens with visible defects. 6.2 Specimens for mechanical properties Prepare six test specimens in accordance with figure 1 or 2, Figure 1 Test specimen with conical shoulders

Dental base metal casting alloys - Tandvård - Basmetallegeringar -

Dental base metal casting alloys - Tandvård - Basmetallegeringar - Part 2: Nickel-based alloys Del 2: Nickelbaserade Iegeringar (ISO 6871-2:1994) (ISO 6871-2:1994) The European Standard EN ISO 6871-2:1996